Prescription drug · ANDA
Norethindrone and ethinyl estradiol NDC 79929-007
Kit · Naari Pte Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79929-007-07 | 7992900070779929000707 | 3 BLISTER PACK in 1 CARTON (79929-007-07) / 1 KIT in 1 BLISTER PACKMarketed from Dec 31, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Norethindrone and ethinyl estradiol
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Naari Pte LimitedNDC labeler code 79929
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206864
- Marketing start
- Listing expires
- Identifiers
- Product ID 79929-007_16aaf795-d54a-9f9c-e063-6394a90a09c4SPL ID 16aaf795-d54a-9f9c-e063-6394a90a09c4SPL set ID 9bd9119e-a874-41e2-ac58-b7f0d155d2fbRxCUI 312033, 748797, 749858
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N479929000707followed by a unit qualifier and the quantityPackage 79929-0007-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Norethindrone and ethinyl estradiol tablets, USP 1 mg/0.035 mg are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typica…
Excerpt only. Read the full label for complete information.
About NDC 79929-007
- What is NDC 79929-007?
- 79929-007 is the product NDC for Norethindrone and ethinyl estradiol kit, listed with the FDA by Naari Pte Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Norethindrone and ethinyl estradiol.
- Who is the labeler?
- Naari Pte Limited, NDC labeler code 79929. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Norethindrone and ethinyl estradiol?
- 1 other product NDC are listed under this name. See all Norethindrone and ethinyl estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norethindrone and ethinyl estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Norethindrone and ethinyl estradiol | — | Kit | Apotex Corp. | 60505-4901 | 60505-4901-08 |
Other NDCs under ANDA 206864
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Norethindrone and ethinyl estradiol | — | Kit | Apotex Corp. | 60505-4901 |